The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho* Serum Elisa Test System.
| Device ID | K833636 |
| 510k Number | K833636 |
| Device Name: | ORTHO* SERUM ELISA TEST SYSTEM |
| Classification | Complement C1q, Antigen, Antiserum, Control |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | DAK |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-17 |
| Decision Date | 1984-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545023744 | K833636 | 000 |
| 00813545023737 | K833636 | 000 |